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W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL WITH HOLES; MESH, SURGICAL, POLYMERIC
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| Model Number 1DLMCPH06 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Adhesion(s) (1695); Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 01/15/2020 |
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Event Type
Injury
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Manufacturer Narrative
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The plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (¿g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (g/cm3)].Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: implant #1 preoperative complaints: on (b)(6) 2010: [facility info not provided.] (b)(6), md.Pre-op history & physical.Chief complaint: abd [abdominal] pain/bulge.Diagnosis: ventral hernia above umbilicus.Abdomen: ventral hernia.Plan: lap [laparoscopic] ventral hernia repair.Risks/benefits: explained.Implant #1 procedure: laparoscopic repair of incarcerated ventral hernia.[implant: gore® dualmesh® plus biomaterial with holes, 1dlmcph06/(b)(4), 18cm x 24cm x 1mm thick] implant #1 date: (b)(6), 2010 [hospitalization dates (b)(6) 2010.] wound classification: unknown.On (b)(6) 2010: (b)(6).(b)(6), md.Operative note.Preoperative diagnosis: umbilical and ventral hernia.Postoperative diagnosis: incarcerated ventral hernia.Surgeon: dr.(b)(6).Assistant: (b)(6).Procedure: ¿after satisfactory prepping and draping the patient's abdomen, a visiport was introduced in the left upper quadrant.Laparoscope was inserted and under direct visualization, 5 mm surgiports were introduced in the left mid abdomen and left lower quadrant.Laparoscope was inserted.Patient was found to have both an umbilical hernia and an incarcerated ventral hernia.The incarcerated omentum was reduced into the abdominal cavity.Then a gore-tex mesh approximately 20 cm x 12 cm oval was inserted and affixed to the anterior abdominal wall with an endo tacker.Fascia at the visiport introduction site was closed with 2-0 pds suture.All air and all instruments were removed.Incisions was closed with 4-0 prolene.The patient tolerated the procedure well.¿ on (b)(6) 2010: (b)(6).(b)(6), md.Post-operative note.[handwritten.] primary surgeon: [illegible.] assistants: (b)(6).Surgical procedure: lap repair inc.Ventral hernia.Specimens removed: none.Estimated blood loss: none.¿[illegible] for d/c [discharge].Rto [return to office] 1 wk [week].¿ on (b)(6) 2010: (b)(6).Implant sticker.¿gore dualmesh® plus biomaterial with holes.¿ ref catalogue number: 1dlmcph06.Lot batch code: (b)(4).Exp 2012-03.W.L.Gore & associates.On (b)(6) 2010: (b)(6).(b)(6), md.Discharge instructions.Activity: limit your activity for 24 hours.Rest.Diet: begin with liquids and light foods ((b)(6), soup, etc.) progress to your normal diet as tolerated.Drink plenty of fluids.Wound care (wash hands with soap and water before and after wound care): keep dressing clean and dry.Special instructions: call doctor if affected extremity becomes cold to touch, blue, tingly, or numb or excessive pain &/or swelling.Appointment: dr.(b)(6) office mon (b)(6) 2010 12:45.Relevant medical information: on (b)(6) 2011: (b)(6).(b)(6), md.Radiology report.Ct scan of the abdomen without contrast.History: abdominal pain, bulge.Comparison: none.Procedure: axial images were obtained from the lung bases to the iliac crests by computed tomography.Oral contrast was administered.Findings: abdomen: ¿the lung bases are clear.The heart size is normal.The limited noncontrast images of the liver are normal.The spleen is normal.No adrenal masses are seen.The aorta is normal in caliber.There is no significant free fluid or adenopathy.There is no nephrolithiasis or hydronephrosis.The patient is status post ventral hernia repair with mesh.Just above the repair, there is a small omental fat containing hernia, the appendix is normal.¿ impression: ¿status post ventral hernia repair with a smell omental fat containing hernia just above the prior repair.Normal appendix.¿ implant #2 preoperative complaints: on (b)(6) 2011: [facility info not provided.] (b)(6), md.Pre-op history & physical.Abdomen: hernia.Impression/diagnosis: ventral hernia recurrent.Plan: lap ventral hernia repair.Risks/benefits: explained.Implant #2 procedure: [procedure name not provided in operative report.] [implant: gore® dualmesh® plus biomaterial with holes, 1dlmcph06/(b)(4), 18cm x 24cm x 1mm thick] implant #2 date: (b)(6) 2011 [hospitalization dates (b)(6), 2011].Wound classification: unknown.On (b)(6) 2011: (b)(6).(b)(6), md.Operative note.Preoperative diagnosis(es): recurrent incisional hernia.Postoperative diagnosis: recurrent incarcerated incisional hernia.Surgeon: (b)(6), md.Assistant: (b)(6), pa-c.Procedure: [not provided.] procedure: ¿after satisfactory general endotracheal anesthesia obtained, the patient¿s abdomen was prepped and draped in usual fashion.Visiport was introduced in the left upper quadrant.Laparoscope was inserted under direct visualization.A 5-mm surgiport was introduced into the left lower quadrant and left upper quadrant.Extensive enterolysis had to be carried out.Incarcerated omentum was reduced from the hernia defect.The patient had hernia defect at the umbilical area and also 4 cm above the umbilicus.After all the adhesions were lysed, an 18 cm x 24 cm gore-tex mesh was inserted and affixed to the anterior abdominal wall with at least 5 cm of overlap in every direction.Both an endo tacker and the superior strap were used.Visiport introduction site was closed with 2-0 pds suture.Then, all air and all instruments removed.Incision closed with 4-0 prolene.The patient tolerated procedure well.¿ on (b)(6) 2011: (b)(6).Implant sticker.¿gore dualmesh® plus biomaterial with holes.¿ ref catalogue number:1dlmcph06.Lot batch code: (b)(4).Exp 2012-04.W.L.Gore & associates.On (b)(6) 2011: (b)(6).(b)(6), md.Post-operative note.[handwritten.] primary surgeon: [illegible.] post-op diagnosis: inc.Recurrent incisional hernia.Surgical procedure: recurrent inc.Hernia repair.Specimens removed: none.Estimated blood loss: 50 cc.On (b)(6) 2011: (b)(6).(b)(6), md.Discharge instructions.Activity: limit your activity for 24 hours.Rest.No lifting.Diet: begin with liquids and light foods ((b)(6), soup, etc.) progress to your normal diet as tolerated.Drink plenty of fluids.Wound care (wash hands with soap and water before and after wound care): remove dressing in 4 days.You may shower then.Observe for infection: increased pain, redness, swelling, foul odor to drainage or pus.If noticed, call your doctor.Observe for excessive bleeding (slow oozing that saturates the dressing or frank bright red blood).In either case, apply pressure to area, elevate it if possible and call your doctor.Appointment: dr.(b)(6) office (b)(6) 2011.Revision preoperative complaints: on (b)(6) 2020: (b)(6).(b)(6) md, (b)(6), md.Emergency room.¿chief complaint: pt arrived with ems as a transfer from big south fork with small bowel obstruction.Pt had an ng tube in place upon arrival.History of present illness: ¿(b)(6) male patient presents to the emergency department via ems complaining of abdominal pain onset x3 days ago.Pt states x1 day ago he went to an urgent care and was given medication for nausea.Pt states he had symptoms similar to this.Pt states the last time he had a normal bowel movement was x4 days ago.Pt states he has had x2 other bowel movements since then, however states they are smaller than normal.Pt states he came from a facility in oneida.Symptoms are located in the center of the abdomen.Symptoms radiate throughout the abdomen.Severity of symptoms are moderate.Symptoms are constant.¿ review of systems: ¿has abdominal pain.Has nausea.Has emesis.Has diarrhea.Has weakness.¿ medical decision making: ¿small bowel obstruction.Vomiting.Abdominal pain.Disposition decision is admit.¿ on (b)(6) 2020: (b)(6).(b)(6), md.History & physical.Assessment/plan: ¿sbo probably secondary to mesh ¿ try medical treatment, keep off anticoagulation ¿ may need surgery.¿ ¿on (b)(6) 2020: (b)(6).(b)(6), md.Diagnostic radiology.Xr [x-ray] small bowel series single contrast.History: sbo [small bowel obstruction].Findings: ¿scout image of the abdomen demonstrates ng tube with tip inside port overlying the stomach.Multiple dilated air-filled small bowel loops in the upper abdomen with hernia mesh over the lower mid abdomen.Following injection of 240 cubic centimeters gastrografin contrast, sequential images of the abdomen are obtained.The patient had one episode of vomiting around the 30-minute image.Over 2.5 hours, minimal contrast empties from the stomach into the proximal small bowel, with patient in upright and right decubitus positions.A delayed image at 5 hours was obtained, but patient vomited between 2.5 and 5-hour images, and there is no residual contrast in the stomach.No evident contrast in the bowel.Impression(s): small bowel obstruction.¿ on (b)(6) 2020: indications: ¿(b)(6) male with history of 2 previous laparoscopic incisional hernia repairs with mesh over 8 years ago who was admitted over the weekend with small-bowel obstruction.He has failed to improve with non-operative measures and small-bowel follow-through showed no progression of contrast, with significant vomiting while the ng tube was clamped.He has been off xarelto for more than 48 hr now and we therefore discussed proceeding with surgery for relief of the obstruction.Extensive conversation was had preoperatively regarding the indications, technical aspects, associated risks and benefits.Risks include but are not limited to bleeding, infection, injury to surrounding structures, risk of anastomotic leak, mesh infection, hernia recurrence, wound complications.He verbalized understanding wished to proceed.¿ revision procedure: laparoscopic lysis of adhesions, modifier -22 due to complexity (see discussion below).Revision date: (b)(6), 2020 [hospitalization dates (b)(6), 2020].Wound classification: 1 - clean.On (b)(6) 2020: (b)(6).(b)(6), md.Operative note.Preoperative diagnosis(es): small bowel obstruction.Postoperative diagnosis(es): small bowel obstruction.Extensive intra-abdominal adhesions.Anesthesia: general.Complications: none.Estimated blood loss: 50 cc.Specimen(s): none.Disposition: stable condition to the recovery room.Findings: ¿extensive intra-abdominal adhesions tethering multiple loops of bowel to the underside of the existing gore-tex mesh, with multiple loops of bowel stuck to the metal tacks.Once this was all free, the actual obstruction was found to be due to extensive interloop adhesions causing essentially closed loop obstruction where the bowel was folded back on itself multiple times.This was all taken down laparoscopically with no evidence of significant serosal injury, and after extensive adhesiolysis the entire small bowel was free.The omentum was pulled down to cover the bowel between the underside of the mesh and the intestine.¿ procedure: ¿the patient was brought to the operating room and placed in the supine position on the operating table.General endotracheal anesthesia was induced without complication, and the patient's abdomen was prepped and draped in standard sterile fashion.A time-out was performed to confirm patient identity, procedure, and administration of preoperative antibiotics.The abdomen was entered in the right upper quadrant using the optiview technique.Incision was made 2 fingerbreadths off the costal margin and the 5 mm optiview trocar was advanced with the camera in place, visualizing each layer of the abdominal wall.Once the peritoneum was entered, the abdomen was insufflated 15 mm mercury inspected; there was no sign of injury from the initial port placement.Attention was turned towards the midline, were [sic] extensive omental adhesions were found to the anterior abdominal wall precluding further visualization.The left upper quadrant was clear, therefore 2nd port was placed under direct visualization in this position.Additional port was then placed in the epigastrium, adhesiolysis proceeded using laparoscopic scissors and electrocautery, meticulously taking down omental adhesions.As dissection proceeded, additional ports were placed under direct visualization of the right and left lower quadrants, working sequentially from all these ports around the abdomen.As the omental adhesions were taken down, significant adhesions from the small bowel to the mesh were found, specifically to the multiple metal tacks around the periphery of the bowel.There were multiple places where the serosa of the bowel was densely adherent to the clips, but with careful dissection with a laparoscopic peanut and the scissors, we were able to clear these without any injury to the bowel itself.Dissection proceeded carefully in this manner until the entire underside of the mesh was clear.The bowel was then carefully inspected and again no serosal injuries were identified.The dilated proximal bowel was run proximally a [sic] to distally until a dense area of interloop adhesions were encountered, but the small bowel was essentially folded back on itself at least 3 times, essentially creating a segment with a closed loop obstruction.Carefully adhesiolysis was then performed in this area, elevating the bowel and carefully using cold scissors to divide dense adhesive bands between loops of bowel.There are at least 3 different areas where the bowel was adhesed to itself, after all this was taken down, the small bowel was now completely free.We were finally able to identify decompressed bowel distally all the way to the ileocecal valve.Thick luminal contents were palpable just proximal to the most obstructed segment, but with gentle manipulation, there was some flow of fluid finally from the dilated proximal bowel distally beyond the obstructed segment.After again carefully inspecting the abdomen finding no evidence of bleeding or of injury to the bowel, the omentum was pulled down in place over the bowel to hopefully protect the bowel from re-adhesing to the underside of the mesh.I attempted to remove some of the metal tacks, but these were densely imbedded in the abdominal wall and i did not feel be possible or safe to remove all of them.After again confirming no bleeding or other issues, the ports removed under direct visualization and the abdomen desufflated.The port sites were closed with subcuticular 4-0 monocryl and dressed with dermabond.All instrument and sponge counts reported as correct prior to the conclusion of the procedure.The patient tolerated the procedure without complication was transferred to the recovery room in stable condition, the family was updated regarding the operative findings immediately at the conclusion of the case.A modifier-22 is applied to this case as this was an extremely difficult dissection requiring almost 3 hr of meticulous adhesiolysis to clear the anterior abdominal wall and then address the dense interloop adhesions causing the actual obstructed segment.This was a reoperative field after 2 previous ventral hernia repairs with 2 different pieces of mesh and multiple metallic tacks which had to be very carefully addressed to prevent injury to the bowel.As such greater than expected time and effort was required to safely complete the procedure.¿ on (b)(6) 2020: (b)(6).(b)(6), md.Discharge summary.Hospital course: ¿(b)(6) male with history of previous laparoscopic ventral hernia repair with mesh and [sic] (b)(6) who presented as a transfer from big south fork on (b)(6) 2020 with small-bowel obstruction.He was initially managed with bowel rest and nasogastric decompression.Small-bowel follow-through was attempted on (b)(6) 2020, but in [sic] emesis with contrast and this study was a limited value but did indicate ongoing obstruction.Given his failure to progress clinically, we discussed proceeding with surgical exploration.He underwent laparoscopic extensive lysis of adhesions on (b)(6) 2020, with intraoperative findings of dense interloop adhesions the cause of bowel obstruction.He would recover quickly following surgery, having resumption of bowel function and tolerated advancement of diet.Pain was controlled for narcotics and was ambulatory.We discussed return precautions and lifting restrictions as well as return to work in detail.He will be discharged home today and follow up in clinic in 3 weeks.¿ physical exam: abdomen: ¿incisions clean, dry dermabond, some ecchymosis extending from the right lower quadrant port site posteriorly towards the flank but no evidence of bleeding.¿ discharge instructions: ¿call for increasing abdominal pain, nausea/vomiting, fever >101, redness or drainage from incisions.No work for 1 week (return on 1/27), then can return with lifting restrictions of nothing greater than 20 lb for 3 weeks.Keep wounds clean and dry, skin glue will flake off in 1-2 weeks.No lifting greater than 20lbs x 4 weeks.May shower immediately.Follow up with (b)(6) (b)(6) 2020 1:30 pm.¿ a potential relationship, if any, between the alleged injuries or complications and the gore device has not been established at this time based on available information.It should be noted that the gore® dualmesh® plus biomaterial with holes instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence." the gore® dualmesh® plus biomaterial with holes instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.".
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Event Description
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It was reported to gore that the patient underwent laparoscopic ventral hernia repair on (b)(6) 2010 and (b)(6) 2011 whereby gore® dualmesh® plus biomaterial with holes were implanted.The complaint alleges that on (b)(6) 2020, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: additional surgery, adhesions, bowel obstruction; recurrence; pain and suffering.Additional event specific information was not provided.
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Manufacturer Narrative
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H6: updated results code.Conclusion code remains unchanged.It should be noted that the gore® dualmesh® plus biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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H6: updated health effect h6: updated investigation finding h6: updated type of investigation h6: updated investigation conclusions.The investigation has been completed.Based upon the totality of the information received over the course of the investigation and reported by gore in the previously submitted medical record narratives the following conclusions have been reached.As previously reported, all pertinent medical records requested may not have been received.Through gore's investigation and based on the available information there is no available information that reasonably suggests that a gore device may have caused or contributed to death, serious injury or reportable malfunction, and is no longer considered reportable.Therefore, this event is being coded as no clinical signs, symptoms or conditions, no health consequences or impact and will be closed as no problem detected.Previous patient codes were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.Following gore¿s investigation, the previously submitted annex f code has been updated to reflect gore¿s final conclusion.It should be noted that the gore® dualmesh® plus biomaterial with holes instructions for use include warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ as with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, compromised device biocompatibility, contamination which may lead to patient harms, device damage, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, defect recurrence and related harms, ileus, increased procedure time and related harms, irritation or inflammation, infection, mesh migration, mesh contraction, pain, paresthesia, perforation, revision/re-intervention, seroma or hematoma and related harms, tissue ischemia, wound complications and wound dehiscence and additional intervention including surgery.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.Based upon the information received, the device remains in the patient and was not available for evaluation.Review of the manufacturing records verified that the lot met all pre-release specifications.C1: the plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (g/cm3)].W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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